Systemic and local intestinal pharmacokinetics of irinoteca

• Conditions: Colorectal cancer; colorectal carcinoma; pancreas carcinoma; 10017990; 10017991

• Registration Number: NL-OMON56972
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Pathologically confirmed malignancy for which treatment with irinotecan is
indicated at a dosing regimen of >= 180 mg/m2 in 2- or 3-weekly treatment
schedules.
• Patients who will start with their first cycle of treatment with chemotherapy
• Age >= 18 years
• Able and willing to give written informed consent
• Patient is able to temporarily store fecal samples in their freezer
• WHO performance status 0-2
• Minimal acceptable safety laboratory values defined as:
o ANC of >= 1.5 x 109 /L
o Platelet count of >= 100 x 109 /L
o Hepatic function as defined by serum bilirubin <= 1.5 x ULN, ALAT and ASAT <=
2.5 x ULN; in case of liver metastases ALAT and ASAT <= 5 x ULN.
o Renal function (eGFR) >= 50 ml/min or creatinine <= 1.5 x ULN

Exclusion Criteria

• Patients with recently performed intestinal surgery including colectomy
• Patients with known substance abuse, psychotic disorders, and/or other
diseases expected to interfere with study or the patient*s safety
• Patients with either a ileostomy, ascending colostomy or transverse colostomy
• Patients unable or unwilling to stop the use of (over the counter) medication
or (herbal)
supplements which can interact with irinotecan (e.g. by induction of inhibition
of CYP3A4)
• Patients with an inability to undergo additional blood sampling.
• Patients with an inability to collect stool samples at home (e.g.
disabilities or incontinency).
• Patients with an inability to read and understand the informed consent form

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified